ABSTRACT
Objective: To quantify, characterize and compare the studies presented to the HCSC CEIm from 2017 to 2020, dividing 2020 into four periods according to the evolution of the COVID-19 pandemic. Material and/or methods: A retrospective analysis was carried out with extraction of the data from the studies from the FUNDANET platform;they were coded and classified according to the type of study, evaluation committee and medical research area. Data were compared via STATA 16. Results: The number of studies during 2017, 2018, 2019 and 2020 were: 636, 726, 725 and 830 respectively. The category with the highest number of studies is Medical Services. The number of studies evaluated in 2020 was higher during the period of confinement and the first wave of the pandemic compared to the rest of the periods studied. It should be noted a statistically significant increase in the number of clinical trials belonging to the Infectious Medical Service, and a non-significant increase in the studies belonging to Central Services. Conclusions: The health crisis derived from the COVID- 19 pandemic has generated the need to reshape the internal work processes of the CEIm to respond in an agile, efficient and rigorous way to the demand for research on SARS-COV2. Despite the limitations, it can be stated that in 2020 an increase in the number of studies in relation to COVID- 19 is observed, although this fact has not constituted a detriment to the research in the other medical areas evaluated. In order to expand the information and make it as reliable and generalizable as possible, it is intended to update the data by collecting information in the next years 2021 and 2022. In addition, it would be appropriate that a research process is started on the subject studied and comparisons with other centres can be established in the future.
ABSTRACT
Objective: To determine the bioequivalence of two oral formulations of paracetamol 500 mg/ibuprofen 200 mg. Tolerability of both formulations of paracetamol/ ibuprofen were evaluated descriptively. Material and/or methods: Twenty-four healthy volunteers were enrolled at this random, single-dose, crossover, two-period design, open-label, bioequivalence study. After overnight fasting, two formulations (test and reference) of paracetamol/ibuprofen (paracetamol 500 mg/ ibuprofen 200-mg film coated tablets), were administered as a single dose on two treatment days separated by a 72 h (minimum) washout period. After dosing, blood samples were drawn for a period of 12 h. Pharmacokinetic parameters were determined from plasma concentrations for both formulations. The coronavirus disease 2019 (COVID-19) pandemic was declared a public health emergency of international concern by the WHO. Extraordinary safety measures were implemented at different levels that intended to preserve the clinical trial activities as far as possible, protecting the safety and preserving the traceability while no vaccine was available. These measures, locally, consisted of: information about the importance of the measures, PCR test for COVID-19 at the screening visit (if IgG serology was positive) and PCR test at every period of admission to Trials Unit, the subject came into the Unit only after a negative result. Results: The highest effort made to assure the safety of participants led to a regular development of the study, with only two cases excluded primarily and one excluded after the first dose administration. Regarding pharmacokinetics, the results found for Paracetamol: Ln (Cmax) ng/ml Ratio 92.83% (CI90: 83.73%-102.94%);Ln (AUClast) h∗ng/ml Ratio: 96.14% (CI90: 93.24%-99.13%);for Ibuprofen: Ln (Cmax) ng/ml Ratio: 93.78% (CI90: 85.43-102.96%), Ln (AUClast) h∗ng/ml Ratio: 96.06% (CI90: 93.75%-98.42%). No drug-related safety concerns appeared. Conclusions: The clinical development of the BE clinical trial was made available by the extraordinary safety measures adopted. The pharmacokinetics results comply with the regulatory requirements for bioequivalence. No significant findings concerning safety were found.